20 July, 2012

 

Ramu Krishnan [2012] APO 41

 

In brief

 

• On 4 April 2012, a delegate of the Commissioner of Patents of the Australian Patent Office refused to grant an application for a patent designed to increase the solubility of cholesterol lowering drugs on the basis that certain claims lacked clarity and novelty.
• The applicant has been allowed 60 days to propose suitable amendments to the 12 claims which were found to lack clarity and/or novelty.

 

The Application

 

On 29 June 2006, Mr Ramu Krishnan filed Australian Standard Patent Application 2006264407 (the "Application") with the Australian Patent Office (the "APO"). The Application was originally filed in India on 4 July 2005 via the Patent Cooperation Treaty (see World Intellectual Property Organization Number WO 2007/004236 A3).

 

The title of the Application is "Improved drug or pharmaceutical compounds and a preparation thereof" and claims a priority date of 4 July 2005.

 

The Application includes 20 claims, which relate to the modification of relatively insoluble drugs into highly soluble forms in order to enable better administration. Mr Krishnan's aim, as described in the patent specification, is to invent modified molecular structures of drugs and pharmaceuticals either in solid form (which are highly soluble in aqueous or non-aqueous solutions) or directly in liquid form, in order to achieve greater bioavailability and bioabsorbability.

 

The preferred drugs to which the invention is targeted are statins – a class of drugs used to lower cholesterol and which typically have poor solubility. Atorvastatin is one of the best-selling statins and is marketed under well-known brands including "Lipitor" and "Torvast". A number of other generic companies now have products registered on the Australian Register of Therapeutic Goods ahead of the expiry of Pfizer's patent for atorvastatin.

 

The specification in the Application states that by improving the solubility of such statins, similar results can be achieved in lower dosages, thereby decreasing the risk of adverse side effects, such as headaches, weakness, insomnia, dizziness, chest pain, rash, diarrhoea and nausea.

 

The Application was the subject of five adverse examination reports and proceeded to a hearing before the Commissioner on 16 January 2012.

 

Construction

 

The Commissioner stated that the construction of claim 1 was "key to the outcome" of the decision. Claim 1 is directed towards a "modified pharmaceutical or drug molecule exhibiting the synergistic properties of enhanced bioavailability and/or enhanced bioabsorbability and/or enhanced solubility … obtainable by reacting a known drug molecule … with a pre-prepared compound as herein described" (emphasis added).

 

"Obtainable"

 

The Commissioner construed the word "obtainable" broadly, by stating that the word "obtainable" to "any" product molecule that could "potentially" result from the reaction defined in the claim. On this construction, "obtainable" did not limit the product molecules in the claim to those "actually produced" by the reaction in the claim. In the Commissioner's view, such a construction was in "sharp contrast" to the likely construction had the claim read "obtained by reacting a known drug molecule" (emphasis added). To this extent, the Commissioner noted that Mr Krishnan had used the terms "obtained" and "obtainable" interchangeably, suggesting that he had "not fully appreciated the distinction between the two terms".

 

"Pre-prepared compound…"

 

The Commissioner considered that the task of construing the phrase "pre-prepared compound" was "difficult" due to the "generalised and often nebulous indications of what compounds are contemplated". In addition, neither the claims nor specification provided any explicit or implicit definition or other guidance on the meaning of the phrase or what it should encompass. The Commissioner, therefore, stated that as the "precise scope" of the phrase was "indeterminate", it should be construed according to its plain meaning, that is, "a compound that already exists".

 

Clarity

 

Section 40(3) of the Patents Act 1990 (Cth) (the "Act") states, inter alia, that claims must be "clear and succinct". Although the Commissioner agreed with Mr Krishnan that a "broad invention" can be difficult to define, she nevertheless found the Application should be refused on the ground of lack of clarity. The Commissioner found that 11 claims lacked clarity as:

 

• the phrase "pre-prepared compound as herein described" is not capable of precise determination; and
• the word "obtainable" further adds to the lack of clarity as it opens the invention up to include a "potentially countless number of modified drugs that may be produced from any (suitable) process whatsoever".

 

Interestingly, the Commissioner was silent on the clarity of the "omnibus claim", "as herein described". Under Australian law, such claims which refer to the description, drawings and/or other examples of a patent specification without expressly stating the technical features of a product or method claimed are allowable, but are construed narrowly.

 

The Australian approach is in contrast with the approach favoured in most overseas jurisdictions, where omnibus claims are not allowed. It should be noted as of 15 April 2013, omnibus claims will no longer be allowed "unless absolutely necessary to define the invention": Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), Schedule 6, Item 43.

 

Novelty

 

Section 7 of the Act states that an invention is deemed to be novel unless it is not novel in light of the prior art. The Commissioner assessed the novelty of all 20 claims in the Application and found that the Application should be refused on the ground of lack of novelty as the subject matter of 11 claims were disclosed in four prior art documents.

 

The examiner had previously objected to various independent and dependent claims on the grounds that those claims were not novel when compared to the disclosures of four prior art documents and/or were obvious to a person skilled in the art as these differences reside in what is merely a choice of one of several known alternatives in the art which would be available for use by the person skilled in the art.

 

The Commissioner noted that the novelty findings in respect of the 11 claims found to lack clarity should not be considered "exhaustive".

 

Opportunity to amend

 

The Commissioner stated that the Application may be amended and those amendments should clarify the phrase "pre-prepared compound as herein described" and restrict the claims to the subject matter found to be novel in the decision. Mr Krishnan has been allowed 60 days to propose suitable amendments.

 

Lessons

 

• The Australian Patent Office will take a broad construction to the adjective "obtainable", as opposed to the verb "obtained". Applicants for patents should consider carefully whether the former is necessary, as its inclusion may render a claim more susceptible to grounds of refusal.
• Applicants for patents should be mindful that omnibus claims will no longer be allowed from 5 April 2013 "unless absolutely necessary to define the invention".